Comparison Between Auto CPAP and Fixed CPAP in Chinese Patients With OSA - Full Text View

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00307424

Purpose

AutoCPAP would lead to better compliance than FixCPAP

Condition	Intervention
Obstructive Sleep Apnea	Device: AutoCPAP Device: FixCPAP

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Comparison of Auto-Continuous Positive Airway Pressure Device(Auto-CPAP) With Conventional Fixed CPAP in Chinese Patients With Obstructive Sleep Apnea (OSA)

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

To compare the compliance of auto-CPAP and fixed CPAP in terms of CPAP usage hours.
To compare the clinical efficacy of auto-CPAP and fixed CPAP in terms of pressure level to abolish OSA, Epworth sleepiness scale and quality of life questionnaire.
To compare patient acceptance of the different type of treatment.

Study Start Date:	August 2004
Estimated Study Completion Date:	June 2005

Detailed Description:

A prospective, randomized crossover cohort. Study subjects consisted of patients newly diagnosed with obstructive sleep apnea (OSA) confirmed with sleep study. All are CPAP naïve.

Randomization:

Arm 1: auto CPAP sleep study then auto CPAP for 2 months Arm 2: fixed CPAP titration then fixed CPAP for 2 months

Then switch over to the other arm

Trial end after 4 months, compliance and other parameters would be compared between two arms as described in the endpoint session.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All subjects should be CPAP naïve.
OSA confirmed with sleep study
Presence of daytime symptoms with excessive daytime sleepiness
Age between 18 to 65
RDI greater than 30
Agreed to participate in trial with informed consent signed

Exclusion Criteria:

Patients not suitable to nasal CPAP because of facial abnormality leading to poor mask fitting.
Patients with known COPD with type II failure
Patients with known heart failure.
Patients with predominant central sleep apnea.
Patients need bilevel positive airway pressure ventilation.
Patients refusing to participate the trial.
Patients have difficulty to follow up regularly.
patients with untreated or under treatment of hypothyroidism

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307424

Locations

China
Prince of Wales Hospital
Hong Kong, China
North District Hospital
Hong Kong, China

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator:

To K Wang, FHKCP

Prince of Wales Hosptial

More Information

No publications provided by Chinese University of Hong Kong

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

To KW, Chan WC, Choo KL, Lam WK, Wong KK, Hui DS. A randomized cross-over study of auto-continuous positive airway pressure versus fixed-continuous positive airway pressure in patients with obstructive sleep apnoea. Respirology. 2008 Jan;13(1):79-86.

Study ID Numbers:	CRE-2004.258-T
Study First Received:	March 27, 2006
Last Updated:	March 27, 2006
ClinicalTrials.gov Identifier:	NCT00307424 History of Changes
Health Authority:	Hong Kong: Hospital Authority; Hong Kong: The Chinese University of Hong Kong

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Nervous System Diseases
Respiration Disorders

Sleep Apnea, Obstructive
Sleep Disorders
Dyssomnias
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on September 11, 2009